Routine Compliance Activities: Execute Periodic System Reviews (PSR), Audit Trail reviews, User Access Management, and backup/restore verification for laboratory systems.
Deviations & Change Control: Manage and investigate qualification deviations, non-conformances, and Out-of-Specification (OOS) events related to equipment qualification. Initiate and manage Change Control protocols for system upgrades or modifications.
Cross-functional Collaboration: Work closely with QC Analysts, Quality Assurance (QA), IT, and external vendors to support site startup, instrument onboarding, and regulatory audit readiness.
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